The Food and Drug Administration (FDA) has caught the manufacturers of Zicam and that should force it, to regulate homeopathic products.
FDA regulations require that drugs and treatments be “scientifically proven safe and effective.” Homeopathic remedies, except when people rely on them to treat serious conditions, are usually safe. So far, though, the FDA has ignored the multi-million dollar fraud. But now there is harm.
The harm, according to hundreds of people and dozens of lawsuits, is that some of Matrixx Initiatives’ homeopathic Zicam cold “treatments” cause anosmia—the loss of smell, a sense necessary both to enjoy a summer day and to detect gas leaks, fires and spoiled food.
Zicam products contain pharmaceutically significant amounts of zinc, which was shown in the 1930s to cause anosmia when used intranasally.
But the giant regulatory loophole that is homeopathy allowed Matrixx, to slap on the label “homeopathic,” slip under the regulatory wire and sell 1 billion doses of untested Zicam.
Under the Obama administration, the FDA requested that Matrixx recall a number of Zicam intranasal products. On June 16, the FDA warned, “Because they are not generally recognized as safe and effective for their labeled uses, these products [must undergo] well-controlled clinical investigations … regardless of their homeopathic status [before re-marketing.]”
While there is conflicting evidence that oral zinc shortens colds, it likely does little harm. The FDA, found Zicam ineffective, thereby fitting it under the agency’s definition of “health fraud.” It also ruled that Zicam’s moneymaking innovation of delivering the chemical into the nose rendered it unsafe.
In addition to the 130 anosmia reports received by the FDA, Matrixx failed to notify the agency of more than 800 Zicam-related complaints. Furthermore, since Zicam was labeled for use by children, a class of underage victims may have gone unnoticed.
Matrixx is currently under investigation by the Securities and Exchange Commission over its handling of the FDA warning and by the Federal Trade Commission for deceptive marketing.
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